ISPE 酸洗钝化.docVIP

11.3 PASSIVATION 11.3 钝化作用 11.3.1 Introduction 11.3.1 简介 Pharmaceutical equipment and high purity water systems are designed so that product contact surfaces are not reactive, additive, or absorptive so the drug product is not adversely altered. High purity water systems are primarily composed of austenitic stainless steel (SS) materials due to their corrosion resistant and contaminant free properties. Passivation is performed to maximize the metals corrosion resistance. The stainless steel is sulfuric/nitric/hydrofluoric acid pickled at the mill to remove manganese sulfide inclusions, scale, and other impurities or imperfections from the surface of the steel. As the steel is removed from the pickling bath, a thin oxide layer forms immediately over the surface. This oxide layer is what renders the stainless steel passive and non-reactive to corrosion. Any 300 series chromium steels containing 17% or more chromium that has been handled, welded, or worked should be passivated prior to service and suitably cleaned prior to passivation. 为了使得药品没有不利变化，在设计制药设备和高纯水系统时，保证它们和产品的接触面是不具有反应性、添加性和吸收性的。考虑到铬镍不锈钢（SS）的抗腐蚀和防污染性，高纯水系统基本上都是由铬镍不锈钢材料构成。钝化作用要做到材料抗腐蚀性的最大程度。不锈钢是将钢浸在硫酸/硝酸/氢氟酸打磨，以去除钢表面的硫化锰类物质、污垢、杂质和缺陷。当从酸浸浴中取出钢时，其表面就会立即形成一层薄薄的氧化物。该氧化物层能使得不锈钢表面不活泼并不具反应性从而不易于腐蚀。300系列的铬钢中，任何系列都含有17％或更多的经处理或焊接的铬，这些铬钢在使用前应钝化，并且在钝化前要做适当的清洁。 Passivation is the method used to fortify the steel surface by strong oxidizing chemicals such as nitric acid. The acid depletes the steel surface of acid soluble species, leaving the highly reactive chromium on the surface in a compounded oxide form. 钝化作用是通过强氧化性的化学试剂如硝酸，来强化钢表面的。酸可减少钢表面的酸可溶性物质，使得表面的高反应性的铬处于复合氧化物形式。 11.3.2 Advantages of Passivation 11.3.2 钝化作用的优点 When SS systems are fabricated, the welding process destroys the existing passive film and compromises the metals ability to ward off the corrosive process. This is particularly applicable in those zones that are either heat affected or have had residues remain in contact with the metal surfac